DuPont Nutrition & Health has received a ‘No Objection’ letter for its Care4U 2´-fucosyllactose (2’-FL), a human milk oligosaccharide (HMO), aimed at narrowing the nutritional gap between breast milk and formula.

“2’-fucosyllactose (2’-FL) is the HMO found in human milk in the greatest abundance,” ​explained Steen Lyck, global business director for HMO, DuPont Nutrition & Health. “Because it is the most abundant, it has naturally been a key initial focus for development and science studies into the potential health benefits supporting digestive, immune and cognitive development.”​

The company’s Care4U 2´-FL HMO previously gained EU approval as a novel food at the start of 2018.

The ingredient, which contains over 98% 2’-FL, was developed in collaboration with Belgium-based Inbiose. Inbiose developed the ingredient by microbial fermentation, a process that DuPont has since improved and commercialized, said Lyck. High purity and density make it easy to use the powder in formulations.

HMOs​

Interest in HMOs is on the rise, specifically in the infant formula space. Human milk oligosaccharides, or HMOs, form a significant portion of human breast milk (about 12%) but they are not easily digested. Experts postulate that their purpose is to jump-start the infant’s microbiome.

Results of a study published in the Journal of Nutrition​​ in 2016 by scientists at Abbott Nutrition found that infants fed a formula with 2’-FL had levels of inflammatory cytokines similar to those observed for breast feeding, and significantly lower than those observed for infants fed a control formula containing no 2’-FL.

The purported health benefits of 2’-FL include digestive health, immune support, and cognitive development by modifying the gut microbiota.

“Human milk remains the best option for nourishing infants, but not all mothers are able to breast-feed their babies. In such cases, it is essential that infant formula is a close second-best. Care4U 2’-FL HMO can help narrow the gap between human milk and infant formula,”​ said Lyck.

“Immune and gut health have been key innovation focuses in the infant formula category,” added Lyck. “In fact, digestive/gut health was the number one claim associated with infant formula launches in 2015, featured on 58% of all launches, according to Innova Market Insights.”​

From babies to adults​

The GRAS affirmation limits the use of the ingredient to infant formula, but there is some early work exploring the potential benefits of HMO consumption in adults​. “Because of the expected selective interaction of HMOs with the human microbiome, investigating benefits of HMOs beyond infants should be an attractive area for future research,”​ added Lyck.